The goal of this clinical research study is to learn about the safety and tolerability of the OnVagus device when used by patients who have metastatic pancreatic cancer and are receiving chemotherapy.
Patients with metastatic pancreatic cancer.
Must have adenocarcinoma component (presence of combined histology is acceptable, as long as adenocarcinoma is present).
Weight loss from baseline of at least 5% (Baseline weight can be anytime from diagnosis onward).
Must have a tissue-based confirmation of diagnosis available. Tissue does not need to be a metastasis; primary tumor or prior surgery are acceptable sources.
History of cervical vagotomy on the right side of neck.
Known structural abnormalities on the right side of neck, including but not limited to situs inversus, bulky R-neck lymphadenopathy, etc., that in the investigators' opinion would lead to inability to correctly place the device onto the vagus nerve.
Implanted electrical device that passes through the neck (e.g.: cranial implant with battery pack in chest, and wires running through the neck).
Metal implants in the neck, including the cervical spine.
Single group
Transcutaneous LFVB (tLFVB)
DeviceThe transcutaneous LFVB (tLFVB), involves placing a superficial, transcutaneous device over the right vagus nerve. The device can be self-applied, after participant/provider education on application is completed. While applied, the device provides the low frequency vagal blockade intended to arrest the cachexia process.
Safety and Adverse Events (AEs)
ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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This trial is not recruiting at the moment. You can still explore other options:
